Orange Book product · Generic (ANDA)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
At a glance
Aug 13, 2021
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 13, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Strength
300MG;50MG;40MG
Dosage form
CAPSULE
Route
ORAL
TE code
AA
Application
ANDA 214087
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- 2024BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 216376 · QUAGEN
- 2024BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 214288 · QUAGEN
- 2024BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 214287 · QUAGEN
- 2022BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 215135 · HIKMA
- 2021BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 215047 · INGENUS PHARMS LLC
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 203647 · STRIDES PHARMA
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 211543 · NESHER PHARMS
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 213046 · TARO
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 213321 · GRANULES
- 2019BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 210817 · DR REDDYS LABS SA
- 2019BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 212082 · LANNETT CO INC
- 2019BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 212083 · LANNETT CO INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
